BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCOMPOSITE PUSHLOCK, 3.5MM X 19.5MM

    MDR report key: 1972606 · Received January 28, 2011

    Report

    Report Number
    1220246-2010-00269
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 30, 2010
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K082810
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED, BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. TWO DEVICES WERE RETURNED. ONE OF THE DEVICE INCLUDES ONLY THE DRIVER. THERE IS NO VISUAL NONCONFORMANCE TO THE DRIVER. SECOND DEVICE INCLUDES THE DRIVER, ORANGE CAP AND BIO-COMPOSITE IMPLANT. BIO-COMPOSITE IMPLANT IS BROKEN OFF APPROXIMATELY 4 THREADS FROM THE DISTAL END. INNER SHAFT OF THE DRIVER IS BENT BETWEEN THE TWO LASER MARKINGS. THERE WAS ALSO A PIECE OF THE BIO-COMPOSITE IMPLANT RETURNED. THERE IS NO SIGNS OF HEAT DAMAGE ON THE BIO-COMPOSITE IMPLANTS FRACTIONS. TYPICALLY THIS TYPE OF EVENT IS CAUSED BY PRYING/LEVERAGING THE DRIVER, PREPARING A PILOT HOLE THAT IS TOO SMALL, INSERTING THE IMPLANT AT AN ANGLE THAT IS NOT CO-AXIAL TO THE PILOT HOLE, AND IMPACTING THE DRIVER BEFORE THE LASER LINE IS FLUSH WITH THE SURFACE OF THE PILOT HOLE. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT NUMBER COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER.

    Description of Event or Problem · 1

    WHILE MALLETING THE PUSHLOCK INTO THE HUMERAL HEAD THE IMPLANT SHATTERED. THIS WAS ALSO ATTEMPTED A SECOND TIME WITH THE SAME RESULT. THE DOCTOR PROCEEDED WITH THE SURGERY AND DID AN OPEN ROTATOR CUFF REPAIR. THIS WAS ORIGINALLY A SHOULDER SCOPE ROTATOR CUFF REPAIR PROCEDURE. A 5.5 PUNCH AND PUSHLOCK PUNCH WAS USED. ALL WAS RETRIEVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOCOMPOSITE PUSHLOCK, 3.5MM X 19.5MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 356305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other